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Introduction: Pulmonary vein isolation (PVI) is effective at treating 50% of unselected patients with persistent atrial fibrillation (AF). Alternatively, PVI combined with a new ablation strategy entitled the Marshall‐PLAN ensures a 78% 1‐year sinus rhythm (SR) maintenance rate in the same population. However, a substantial subset of patients could undergo the Marshall‐PLAN unnecessarily. It is therefore essential to identify those patients who can be treated with PVI alone versus those who may truly benefit from the Marshall‐PLAN before ablation is performed. In this context, we hypothesized that electrical cardioversion (EC) could help to select the most appropriate strategy for each patient. Methods: In this multicentre, prospective, randomized study, patients with AF recurrence within 4 weeks after EC will be randomized 1:1 to PVI alone or the Marshall‐PLAN. Conversely, patients in whom SR is maintained for ≥4 weeks after EC will be treated with PVI only and included in a prospective registry. The primary endpoint will be the 1‐year SR maintenance rate after a single ablation procedure. Results and Conclusion: The Marshall‐PLAN might be necessary in patients with an advanced degree of persistent AF (i.e., where SR is not maintained for ≥4 uninterrupted weeks after EC). Conversely, in patients with mild or moderate persistent AF (i.e., where SR is maintained for ≥4 weeks after EC), PVI alone might be a sufficient ablation strategy. The PACIFIC trial is the first study designed to assess whether rhythm monitoring after EC could help to identify patients who should undergo adjunctive ablation strategies beyond PVI. [ABSTRACT FROM AUTHOR]

Objective: Pulmonary vein isolation (PVI) guided by a standardised CLOSE (contiguous optimised lesions) protocol has been shown to increase clinical success after catheter ablation for paroxysmal atrial fibrillation (PAF). This study analysed healthcare utilisation and quality of life (QOL) outcomes from a large multicentre prospective study, measured association between QOL and atrial fibrillation (AF) burden and identified factors associated with lack of QOL improvement.Methods: CLOSE-guided ablation was performed in 329 consecutive patients (age 61.4 years, 60.8% male) with drug-refractory PAF in 17 European centres. QOL was measured at baseline and 12 months post-ablation via Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT) and EuroQoL EQ-5D-5L questionnaires. All-cause and cardiovascular hospitalisations and cardioversions over 12 months pre-ablation and post-ablation were recorded. Rhythm monitoring included weekly and symptom-driven trans-telephonic monitoring, plus ECG and Holter monitoring at 3, 6 and 12 months. AF burden was defined as the percentage of postblanking tracings with an atrial tachyarrhythmia ≥30 s. Continuous measures across multiple time points were analysed using paired t-tests, and associations between various continuous measures were analysed using independent sample t-tests. Each statistical test used two-sided p values with a significance level of 0.05.Results: Both QOL instruments showed significant 12-month improvements across all domains: AFEQT score increased 25.1-37.5 points and 33.3%-50.8% fewer patients reporting any problem across EuroQoL EQ-5D-5L domains. Overall, AFEQT improvement was highly associated with AF burden (p=0.009 for <10% vs ≥10% burden, p<0.001 for <20% vs ≥20% burden). Cardiovascular hospitalisations were significantly decreased after ablation (42%, p=0.001). Patients without substantial improvement in AFEQT (55/301, 18.2%) had higher AFEQT and CHA2DS2-VASc scores at baseline, and higher AF burden following PVI.Conclusions: QOL improved and healthcare utilisation decreased significantly after ablation with a standardised CLOSE protocol. QOL improvement was significantly associated with impairment at baseline and AF burden after ablation.Trial Registration Number: NCT03062046. [ABSTRACT FROM AUTHOR]

Background: The assessment of noninvasive markers of left atrial (LA) low‐voltage substrate (LVS) enables the identification of atrial fibrillation (AF) patients at risk for arrhythmia recurrence after pulmonary vein isolation (PVI). Methods: In this prospective multicenter study, 292 consecutive AF patients (72% male, 62 ± 11 years, 65% persistent AF) underwent high‐density LA voltage mapping in sinus rhythm. LA‐LVS (<0.5 mV) was considered as significant at 2 cm2 or above. Preprocedural clinical electrocardiogram and echocardiographic data were assessed to identify predictors of LA‐LVS. The role of the identified LA‐LVS markers in predicting 1‐year arrhythmia freedom after PVI was assessed in 245 patients. Results: Significant LA‐LVS was identified in 123 (42%) patients. The amplified sinus P‐wave duration (APWD) best predicted LA‐LVS, with a 148‐ms value providing the best‐balanced sensitivity (0.81) and specificity (0.88). An APWD over 160 ms was associated with LA‐LVS in 96% of patients, whereas an APWD under 145 ms in 15%. Remaining gray zones improved their accuracy by introduction of systolic pulmonary artery pressure (sPAP) of 35 mmHg or above, age, and sex. According to COX regression, the risk of arrhythmia recurrence 12 months following PVI was twofold and threefold higher in patients with APWD 145–160 and over 160 ms, compared to APWD under 145 ms. Integration of pulmonary hypertension further improved the outcome prediction in the intermediate APWD group: Patients with APWD 145–160 ms and normal sPAP had similar outcome than patients with APWD under 145 ms (hazard ratio [HR] 1.62, p =.14), whereas high sPAP implied worse outcome (HR 2.56, p <.001). Conclusions: The APWD identifies LA‐LVS and risk for arrhythmia recurrence after PVI. Our prediction model becomes optimized by means of integration of the pulmonary artery pressure. [ABSTRACT FROM AUTHOR]

Abstract: Background: Advancements in electrophysiology 3‐D mapping systems facilitate the broadening scope of electrophysiology study and catheter ablation to treat complex arrhythmias. While electroanatomical mapping systems have default settings available for a variety of mapping parameters, significant operator customization driven by arrhythmia type and experience can occur. However, multicenter comprehensive reporting of customized mapping settings is lacking. Methods: In this prospective, multicenter observational registry, subjects with cardiac arrhythmias underwent electrophysiology study and ablation procedure using the EnSite Precision™ electroanatomical mapping system per standard of care, and associated automated mapping thresholds and procedural characteristics were observed. Results: Cardiac mapping and ablation was performed in 503 patients (64.4% male, 59.6 ± 13.2 years) for a variety of indications including atrial fibrillation (N = 277), atrial flutter (N = 67), other supraventricular tachycardias (N = 96), and ventricular tachycardia (N = 56). Automated electroanatomical mapping was used to generate 88.2% of all maps, and arrhythmia‐specific adjustments of mapping thresholds were utilized to collect electrophysiologically relevant data. The most commonly used thresholds for mapping in AF were Distance (average 2.7 ± 3.5 mm) and Signal‐to‐Noise Ratio (5.2 ± 1.1), while mapping in VT commonly used Score (88.5 ± 6.5%) and Distance (0.6 ± 0.5 mm). Automated mapping collected and utilized 8.8 times more data than manual mapping without increasing mapping time. Conclusions: This registry revealed arrhythmia‐specific automated mapping settings used to generate electroanatomical maps of multiple cardiac rhythms with higher point density than manual mapping without increasing mapping time. Commonly used mapping threshold settings could serve as an important reference for new automated electroanatomical mapping users or those expanding their usage to new indications and arrhythmias. [ABSTRACT FROM AUTHOR]

Aims: Non-invasive electrocardiogram (ECG) mapping allows the activation of the entire atrial epicardium to be recorded simultaneously, potentially identifying mechanisms critical for atrial fibrillation (AF) persistence. We sought to evaluate the utility of ECG mapping as a practical tool prior to ablation of persistent AF (PsAF) in centres with no practical experience of the system.Methods and Results: A total of 118 patients with continuous AF duration <1 year were prospectively studied at 8 European centres. Patients were on a median of 1 antiarrhythmic drug (AAD) that had failed to restore sinus rhythm. Electrocardiogram mapping (ECVUE™, CardioInsight, USA) was performed prior to ablation to map AF drivers (local re-entrant circuits or focal breakthroughs). Ablation targeted drivers depicted by the system, followed by pulmonary vein (PV) isolation, and finally left atrial linear ablation if AF persisted. The primary endpoint was AF termination. Totally, 4.9 ± 1.0 driver sites were mapped per patient with a cumulative mapping time of 16 ± 2 s. Of these, 53% of drivers were located in the left atrium, 27% in the right atrium, and 20% in the anterior interatrial groove. Driver-only ablation resulted in AF termination in 75 of the 118 patients (64%) with a mean radiofrequency (RF) duration of 46 ± 28 min. Acute termination rates were not significantly different amongst all 8 centres (P = 0.672). Ten additional patients terminated with PV isolation and lines resulting in a total AF termination rate of 72%. Total RF duration was 75 ± 27 min. At 1-year follow-up, 78% of the patients were off AADs and 77% of the patients were free from AF recurrence. Of the patients with no AF recurrence, 49% experienced at least one episode of atrial tachycardia (AT) which required either continued AAD therapy, cardioversion, or repeat ablation.Conclusion: Non-invasive mapping identifies biatrial drivers that are critical in PsAF. This is validated by successful AF termination in the majority of patients treated in centres with no experience of the system. Ablation targeting these drivers results in favourable AF-free survival at 1 year, albeit with a significant rate of AT recurrence requiring further management. [ABSTRACT FROM AUTHOR]

Background Atrial fibrillation (AF) progressively leads to electrical remodeling (ER) and anatomical-mechanical remodeling (AR), whose relationships in humans remain poorly known. Methods ER and AR were compared in patients undergoing percutaneous radiofrequency (RF) ablation for AF. ER was defined by right and left appendage activation rates as a surrogate for atrial refractory periods. AR was approached by left atrial (LA) diameters and area and left atrial appendage (LAA) area and contractile function (mean emptying flow velocity) (LAAFV) before RF ablation. Mean duration between successive LAA contractions was considered as LAA mechanical rate. Results Forty-one patients (31 men, age: 64 ± 9 years) with paroxysmal (27%), persistent (61%), or long-persistent AF (12%) were prospectively included (ejection fraction: 44 ± 16%). Parameters exploring AR were highly correlated to each other: LA area (28 ± 7 cm2), LAA area (5.7 ± 2.25 cm2), LA transverse (49 ± 7 mm), and anteroposterior diameter (59 ± 13 mm) or LAAFV (29 ± 13 cm/s; P < 0.05 for each comparison). Parameters exploring ER were also highly correlated: right atrial appendage (RAA; 181 ± 39 ms) and LAA (176 ± 33 ms) activation rates (P < 0.0001). There was no significant correlation between any ER and AR parameter. Only LAA mechanical rate (174 ± 36 ms) was correlated to LAA or RAA activations rates (P ≤ 0.01). Conclusion ER and AR are not mutually related, atrial activation rate being not correlated to LA or LAA size or function. Thus, the mechanisms leading to AF-induced atrial remodeling may differ for anatomical and electrophysiological aspects. [ABSTRACT FROM AUTHOR]

Background: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia imposing substantial morbidity and mortality. Catheter-based pulmonary vein isolation (PVI) using radiofrequency current (RFC) has become a standard treatment for drug-resistant and symptomatic paroxysmal AF (PAF). In recent years, the cryoballoon-based technique is increasingly used as a promising alternative with a short learning curve. Methods: The FIRE AND ICE trial is a prospective, randomized, controlled, open, blinded outcome assessment, noninferiority trial comparing cryoballoon-, and RFC-based PVI. Patients with drug-resistant PAF will be randomized in a 1:1 matrix in multiple European centers. The primary hypothesis is that cryoballoon ablation is not inferior to RFC ablation using 3-dimensional mapping with respect to clinical efficacy. The primary endpoint is defined as the time to first documented clinical failure, including: (1) recurrence of AF; (2) atrial flutter or atrial tachycardia; (3) prescription of class I or III antiarrhythmic drugs; or (4) re-ablation, whichever comes first, following a blanking period of 3 months after the index ablation procedure. The primary safety endpoint is a composite of death, stroke/transient ischemic attack, cardiac arrhythmias (apart from AF recurrence) causally related to the therapeutic intervention, and procedure-related serious adverse events. Conclusion: The FIRE AND ICE trial compares 2 different technologies to perform catheter ablation of PAF with respect to efficacy and safety. It aims at providing objective data to guide selection and usage of ablation catheters in the treatment of AF. [ABSTRACT FROM AUTHOR]

Background: Current guidelines recommend pulmonary-vein isolation by means of catheter ablation as treatment for drug-refractory paroxysmal atrial fibrillation. Radiofrequency ablation is the most common method, and cryoballoon ablation is the second most frequently used technology.Methods: We conducted a multicenter, randomized trial to determine whether cryoballoon ablation was noninferior to radiofrequency ablation in symptomatic patients with drug-refractory paroxysmal atrial fibrillation. The primary efficacy end point in a time-to-event analysis was the first documented clinical failure (recurrence of atrial fibrillation, occurrence of atrial flutter or atrial tachycardia, use of antiarrhythmic drugs, or repeat ablation) following a 90-day period after the index ablation. The noninferiority margin was prespecified as a hazard ratio of 1.43. The primary safety end point was a composite of death, cerebrovascular events, or serious treatment-related adverse events.Results: A total of 762 patients underwent randomization (378 assigned to cryoballoon ablation and 384 assigned to radiofrequency ablation). The mean duration of follow-up was 1.5 years. The primary efficacy end point occurred in 138 patients in the cryoballoon group and in 143 in the radiofrequency group (1-year Kaplan-Meier event rate estimates, 34.6% and 35.9%, respectively; hazard ratio, 0.96; 95% confidence interval [CI], 0.76 to 1.22; P<0.001 for noninferiority). The primary safety end point occurred in 40 patients in the cryoballoon group and in 51 patients in the radiofrequency group (1-year Kaplan-Meier event rate estimates, 10.2% and 12.8%, respectively; hazard ratio, 0.78; 95% CI, 0.52 to 1.18; P=0.24).Conclusions: In this randomized trial, cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation, and there was no significant difference between the two methods with regard to overall safety. (Funded by Medtronic; FIRE AND ICE ClinicalTrials.gov number, NCT01490814.). [ABSTRACT FROM AUTHOR]